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Incidence of ADRs
| Safety analysis set (N = 538)a | Number of events (per 100 person-years) | |
|---|---|---|
| Any ADRs occurring in ≥ 1% of patients | 112 (20.8) | 24.9 |
| Serious ADRs occurring in ≥ 1% of patients | 8 (1.5) | 2.4 |
| Gastrointestinal disorders | 86 (16.0) | 16.6 |
| Diarrhoea | 43 (8.0) | 6.9 |
| Faeces soft | 23 (4.3) | 3.5 |
| Stomatitis | 10 (1.9) | 1.4 |
| Abdominal pain | 7 (1.3) | 1.0 |
| Skin and subcutaneous tissue disorders | 17 (3.2) | 5.2 |
| Rash | 9 (1.7) | 1.3 |
aData are presented as n (%)
ADR adverse drug reaction
